Direct comparison of the specialised blood fibrosis tests FibroMeter^V2G and Enhanced Liver Fibrosis score in patients with non‐alcoholic fatty liver disease from tertiary care centres

Abstract

Summary Background The Enhanced Liver Fibrosis score (ELF) and the FibroMeterV2G are two specialized blood fibrosis tests which include direct markers of liver fibrosis. They have been shown to be more accurate than the simple blood fibrosis tests FIB4 and the non‐alcoholic fatty liver disease (NAFLD) fibrosis score (NFS). Aims To directly compare the accuracies of ELF and FibroMeterV2G for the non‐invasive diagnosis of liver fibrosis in NAFLD. Methods Four hundred and seventeen patients with biopsy‐proven NAFLD were enrolled from two tertiary care centres. Four blood fibrosis tests were calculated: ELF, FibroMeterV2G, NFS, and FIB4. Advanced fibrosis F3/4 on liver biopsy (NASH CRN scoring) was the primary endpoint. Results Areas under the receiver operating characteristic (AUROC) curve for advanced fibrosis were not significantly different between the direct markers of liver fibrosis (hyaluronate, PIIINP, TIMP‐1, alpha2‐macroglobulin) and the simple blood fibrosis tests NFS and FIB4. ELF (0.793 ± 0.022) and FibroMeterV2G (0.804 ± 0.021) had significantly higher AUROC than NFS (0.722 ± 0.025, P < .010) and FIB4 (0.739 ± 0.024, P < .020). AUROC for advanced fibrosis and Obuchowski index were not significantly different between ELF and FibroMeterV2G. Algorithms using first ELF or FibroMeterV2G and then liver biopsy in case of undetermined diagnosis provided high diagnostic accuracy for advanced fibrosis: 90% sensitivity, 90% specificity, 93% negative predictive value, 85% positive predictive value, and 90% correct classification. In these algorithms, the rate of liver biopsy was 45.3% with ELF versus 39.3% with FibroMeterV2G (P = .065). Conclusions ELF and FibroMeterV2G have equal accuracy and perform better than the simple FIB4 and NFS tests for the non‐invasive diagnosis of advanced liver fibrosis in patients with NAFLD from tertiary care centres.

The Intricate Relationship between Type 2 Diabetes Mellitus (T2DM), Insulin Resistance (IR), and Nonalcoholic Fatty Liver Disease (NAFLD)

“…Experts propose as the gold standard for detection and grading of the hepatic steatosis, using the intrahepatic TG measurement with the magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) [128,129]. Subjects with intermediate or high risk of severe fibrosis may benefit from FibroMeter that performs better than the simple FIB4 and NFS tests, and can measure the hepatic extracellular matrix components [130]. Also, Ampuero et al [131] developed and validated recently the Hepamet fibrosis scoring system, a noninvasive scoring test with 97.2% specificity and 74% sensitivity that uses clinical and laboratory information from NAFLD subjects and can identify fibrosis stage with better accuracy than NFS and FIB-4.…”

Advances in non-invasive assessment of hepatic fibrosis

“…+++++AUC ≥0.90, ++++AUC 0.85–0.89, +++AUC 0.80–0.84, ++AUC 0.75–0.79, +AUC <0.75 (Harrell’s c index substituted for AUC for prognostic category).*Accuracy for determining advanced (bridging) fibrosis abstracted from meta-analyses where available7 9 12 118 or from large cohorts of chronic liver disease patients 26 59 74 119–123†Proportion of cases falling within an indeterminate range for the prediction of advanced fibrosis 6 38 72 119 120 124–127‡AUC for significant (F2-4) fibrosis.ALD, alcoholic liver disease; ALT, alanine aminotransferase; Apo-A1, apolipoprotein-A1; APRI, AST-Platelet Ratio Index; AST, aspartate aminotransferase; AUC, area under the curve; BMI, body mass index; CHB, Chronic hepatitis B; CHC, chronic hepatitis C; HA, hyaluranic acid; IFG, impaired fasting glucose; α2-M, α2-macroglobulin; NA, not applicable; NAFLD, non-alcoholic fatty liver disease; PNPIII, procollagen N-terminal peptide III; PSC, primary sclerosing cholangitis; PTI, prothrombin index; TIMP-1, tissue inhibitor of matrix metalloproteinase-1.…”

“…†Proportion of cases falling within an indeterminate range for the prediction of advanced fibrosis 6 38 72 119 120 124–127…”

Protocol for a phase IV, open-label feasibility study investigating non-invasive markers of hepatic fibrosis in people living with HIV-1 and non-alcoholic fatty liver disease randomised to receiving optimised background therapy (OBT) plus maraviroc or OBT alone

“…24 Other studies have confirmed the accuracy of the ELF score in the assessment of hepatic fibrosis in PLWH and in those with NAFLD. [25][26][27][28] Assuming the SD of the ELF score is 1.12, with 20 patients in each group for the analysis, a difference in ELF of 1 point can be estimated with a 95% CI from 0.6 to 1.4. Assuming an attrition rate of 33%, a target of 30 individuals will be recruited per group.…”